Applies skill and dexterity in the assembly of components into finished devices, in keeping with regulatory and company guidelines.
Use higher level tools and equipment - which may include one or more of the following welders, solders, ovens, autoclaves, microscopes, magnifiers, scissors, knives, or others - for more complex assembly operations that typically require 20+ hours of training including packaging/labeling in the manufacturing process of medical device components.
Self-assessment of work, which may include visual inspection under a microscope, and sequential review of colleagues work, providing constructive team feedback, based on SOPs and quality guidelines; including escalating work issues and changes in equipment performance to supervisor for assessment and correction, including reworking units as required.
Assure appropriate settings and parameters of equipment for precise assembly and inspection of medical devices, in a timely fashion at each work station, following work order instructions and drawings, using computers to navigate drawings, and entering parts status data.
Inventory reconciliation at start of day and when transitioning to next work order.
Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE.
On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.
Other incidental duties: General work area housekeeping, attend trainings, meetings, special assignments and other miscellaneous tasks, perform other duties as assigned by Supervisor.
Education and Experience:
H.S. Diploma or equivalent and two(2) years previous related experience, required.
Previous experience working in a manufacturing environment, preferred.
Availability to work rotating shifts, holidays and weekends.
Good understanding of manufacturing procedures and continuously expands proficiency in all operations for multiple models.
Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures.
Good communication skills.
Able to read and comprehend English, and elementary-level understanding of numerical functions.
Basic computer and mathematics skill.
Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
Must be able to work with minimum supervision by following detailed manufacturing instructions.
Work in a Team environment, primarily with colleagues and supervisor.
Flexibility to work overtime and varying shifts.
Accountable to adhere to applicable Edwards Environmental, Health and Safety and Quality System requirements to ensure our products and services consistently meet customer and regulatory.
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
Ensure proper handling, storage and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests and coordinate proper training sessions to affected personnel.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.